Duns Number:188354831
Device Description: 1. 10x 6-well HEp 2 ANA Substrate Slides2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 50408 1. 10x 6-well HEp 2 ANA Substrate Slides2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 504088)3. 1x mL Centromere Positive Control4. 1x 1mL IFA System Negative Control5. 1x 7mL FITC IgG (H&L) HEp Conjugate6. 1x 3mL PVA Mounting Medium7. 2x 25mL PBS II Concentrate (40x)8. 1x 3mL 1% Evans Blue9. 1x 10 Coverslips
Catalog Number
-
Brand Name
NOVA Lite® HEp-2 External EB Kits
Version/Model Number
704230
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 01, 2019
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DHN
Product Code Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Public Device Record Key
96c87589-891f-45d1-b211-02d337ada70c
Public Version Date
September 12, 2019
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 215 |